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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXCOM, INC DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

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DEXCOM, INC DEXCOM G6 INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED Back to Search Results
Model Number G6
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091)
Event Date 02/15/2021
Event Type  Injury  
Event Description
Use dexcom g6. It started itchy quickly but could keep it on even through the itch. After taking it off, lots of itching, blisters, red. Fda safety report id # (b)(4).
 
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Brand NameDEXCOM G6
Type of DeviceINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
Manufacturer (Section D)
DEXCOM, INC
MDR Report Key11412432
MDR Text Key235029000
Report NumberMW5099774
Device Sequence Number1
Product Code QBJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/01/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/03/2021 Patient Sequence Number: 1
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